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Cold plasma could spark faster healing for chronic wounds
NCT ID NCT07251426
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding cold atmospheric plasma (CAP) to standard wound care helps diabetic foot and venous leg ulcers heal faster and stay healed longer. About 494 adults with these chronic wounds will receive either standard care alone or standard care plus CAP. The goal is to see if CAP can reduce infection, stimulate healing, and improve quality of life.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 494 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2025
An estimate. Start dates often move.
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 1\. is referred to one of the participating hospitals for treatment of a diabetic foot ulcer (DFU) or venous leg ulcer (VLU) with healing stagnation and a. For VLU: i. An ulcer on the lower leg resulting from malfunctioning venous valves in the leg veins. b. For DFU: i. An ulcer on the foot or lower leg in person with currently or previously diagnosed diabetes mellitus and usually accompanied by neuropathy and/or peripheral artery disease (PAD) in the lower extremity Note: In patients with both diabetes and chronic venous insufficiency, ulcers will be categorized as DFU in case of symptoms of diabetic neuropathy or loss of protective sensation, and otherwise categorized as VLU. 2\. has a wound with a minimum wound surface area of 0.5 cm2 and a maximum diameter of 6 cm (\~28 cm2 wound surface area for circular wounds; measured after debridement), 3\. has a minimum age of 18 years old. Exclusion Criteria: * 1\. the participant has one or more of the following contraindications for PLASOMA: 1. extreme exudative wounds, i.e. wounds in which moisture is visible within seconds after patting dry; 2. any implanted active electronic device, such as a pacemaker, is present; 3. an electronic medical device attached to the body, for example electronic life support equipment, a hearing aid, insulin pump or dialysis machine. If this medical device can be disconnected, PLASOMA treatment may be performed. If the sole purpose of this medical device is monitoring, such as a glucose sensor, PLASOMA treatment is not contra-indicated but note that use of PLASOMA together with such devices has not been tested and may lead to erroneous operation of the attached device during PLASOMA treatment; 4. metal in the area 10 cm around pad-electrode area, e.g. metal sutures and implants; 5. connection from outside the body to (near) the heart is present, e.g. a central venous catheter; 6. the participant has epilepsy; 7. the participant is pregnant. 2\. the participant has more than one wound that requires professional wound care. 3\. for DFU the WIfI-classification is wound grade 3, defined as an extensive, deep ulcer involving forefoot and/or midfoot; deep, full thickness heel ulcer + calcaneal involvement. 4\. presence of ischemia grade 2 or 3, according to the WIfI classification (= the ankle-brachial pressure index (ABI) is ≤0.59 OR the ankle systolic pressure is ≤69 mmHg OR the toe pressure is ≤39 mmHg; there should be at least one of these three measurements available). 5\. a deep infection defined as an infection of the wound involving structures deeper than skin and subcutaneous tissues (e.g., abscess, osteomyelitis, septic arthritis, fasciitis). 6\. the wound is located on a toe. 7\. the participant receives treatment with immunosuppressive agents or oral corticosteroids; no exclusion if participant has received a stable dose for at least 2 months and the oral corticosteroid dose does not exceed 7.5 mg/day prednisone or equivalent. 8\. the participant is receiving or likely to receive offloading with a total contact cast or advanced wound therapies - such as negative pressure therapy, hyperbaric oxygen therapy, biologicals (e.g. skin substitutes, growth factors), electrophysical therapy - for the to be-treated wound. Advanced wound dressings (including but not limited to hydrocolloid, hydrogel, alginate, collagen and antimicrobial dressings) are not excluded. 9\. presence of a chronic or active skin disorder that may negatively influence wound healing (such as Marfan or Ehlers-Danlos syndrome). 10\. the participant takes part in another study that is likely to compromise the outcome of this study or the feasibility of the participant fulfilling this study. 11\. the participant is lactating. 12\. the participant is unable to provide consent.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
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How to take part
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The official record
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A doctor treating you
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Other studies related to the condition(s) this trial covers.
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